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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 October 2023 |
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Main ID: |
NCT03048331 |
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Date of registration:
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07/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Functional Electrical Stimulation (FES) and Reconstructive Tetraplegia Hand and Arm Surgery
FES |
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Scientific title:
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The Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - A Pilot Study |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03048331 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Ines Bersch, MSc |
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Address:
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Telephone:
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+41 41 9394206 |
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Email:
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ines.bersch@paraplegie.ch |
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Affiliation:
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Name:
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Jan Fridèn, Prof.med. |
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Address:
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Telephone:
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+41 41 939 5203 |
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Email:
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jan.friden@paraplegie.ch |
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Affiliation:
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Name:
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Jan Fridèn, Prof.med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Swiss Paraplegic Centre Nottwil, Switzerland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- traumatic or non-traumatic (> 6 month) spinal cord injury
- Age = 18 years
- Level of lesion C4 - Th1
- American Spinal Cord Injury Association Impairment Scale (AIS) A/B/C/D
- Planned reconstructive hand or arm surgery at the Swiss Paraplegic Centre Nottwil
- Signed informed consent
Exclusion Criteria:
- Patients during primary rehabilitation
- Patients' inability to follow the study, e.g. mental-health problems, language
problems, dementia etc.
- Pregnancy (anamnestic)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injury Cervical
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Intervention(s)
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Device: Functional Electrical Stimulation
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Primary Outcome(s)
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Change in evoked force
[Time Frame: 12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery]
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Change in power output
[Time Frame: 12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery]
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Secondary Outcome(s)
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Change in muscle volume
[Time Frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery]
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Change in muscle activity
[Time Frame: 4 weeks post-surgery and 16 weeks post-surgery]
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Change in Canadian Occupational Performance Measurement (COPM)
[Time Frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery]
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Change in the treatment effectiveness
[Time Frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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